癌研連線CancerLink
進行中（不再收案） NCT05382299

Sacituzumab Govitecan-hziy 對比研究者選擇治療用於既往未接受治療的局部晚期不可手術或轉移性三陰性乳癌患者的研究

乳癌肉瘤Phase IIII 期III 期IV 期PD-L1

本研究的主要目標是比較 sacituzumab govitecan-hziy（SG）與研究者選擇治療（TPC）在既往未接受治療、局部晚期、不可手術或轉移性三陰性乳癌參與者中的無惡化存活期（PFS），該等參與者的腫瘤不表達程序性細胞死亡配體1（PD-L1），或參與者既往曾接受抗程序性細胞死亡（配體或蛋白）1（Anti-PD-(L)1）治療。

適應症：Triple Negative Breast Cancer、PD-L1 Negative

收案條件

納入條件

  • Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
  • Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
  • Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
  • Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
  • Individuals presenting with de novo metastatic TNBC are eligible
  • Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Demonstrates adequate organ function
  • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
  • Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease

排除條件

  • Positive serum pregnancy test or women who are lactating
  • Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
  • Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
  • May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
  • Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
  • Active second malignancy
  • Active serious infection requiring antibiotics
  • Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。